Abstract 4370601: Efficacy of Icosapent Ethyl for Cardiovascular Risk Reduction by Aspirin Use in REDUCE-IT
Bibliographic record
Abstract
Background: Icosapent ethyl, a purified eicosapentaenoic acid, has demonstrated CV risk reduction. Emerging evidence suggests that the antiplatelet effects of icosapent ethyl may contribute to this CV benefit. Hypothesis: Clinical outcomes with icosapent ethyl among patients with or without aspirin use have not been reported. This is an important evidence gap given the potential overlapping antiplatelet effects. Methods: REDUCE-IT was a double-blind clinical trial randomizing patients to icosapent ethyl (2g twice per day) or placebo. Statin-treated patients with elevated triglycerides (135-499 mg/dL), controlled LDL-C (41-100 mg/dL), and increased CV risk were included. In this analysis, patients with or without aspirin use were included and evaluated by randomization group. Patients were assessed overall as well as among the primary and secondary (prior CV disease) prevention cohort. The primary composite endpoint included events of nonfatal MI, nonfatal stroke, coronary revascularization, hospitalization for unstable angina, or CV death. The key secondary endpoint included events of nonfatal MI, nonfatal stroke, or CV death. Results: Among 8179 patients, 6179 (75.5%) were with aspirin use. Icosapent ethyl significantly reduced the primary endpoint events compared with placebo (67.3 vs 99.1 events/1000 patient-years [p-y]; Rate Ratio (RR): 0.69 [95% CI: 0.61, 0.77]; P<0.0001), with consistent effects among those with aspirin use (70.2 vs 109.4 events/1000 p-y; RR: 0.64 [95% CI: 0.56, 0.74]) or without (57.9 vs 67.2 events/1000 p-y; RR: 0.85 [95% CI: 0.65, 1.11]) (Pinteraction[int]=0.15) ( Figure ). Similar benefits were observed with icosapent ethyl for key secondary composite endpoint events (Pint=0.20). Findings were numerically similar in the primary prevention cohort, though not statistically significant. Among 5785 patients in the secondary prevention cohort, icosapent ethyl similarly reduced primary endpoint events (78.8 vs 120.8 events/1000 p-y; RR: 0.65 [95% CI: 0.57, 0.74]; P<0.0001), with consistency among those with aspirin use (75.9 vs 123.7 events/1000 p-y; RR: 0.61 [95% CI: 0.53, 0.70]) or without (95.6 vs 104.8 events/1000 p-y; RR: 0.89 [95% CI: 0.64, 1.23]) (Pint=0.12). Conclusion: Among patients with elevated triglycerides, controlled LDL, and high CV risk, icosapent ethyl reduced CV outcomes irrespective of aspirin use. These findings suggest icosapent ethyl has CV benefit incremental to concomitant background therapy with statins plus aspirin.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".